NCT04122937

Brief Summary

Inflammation plays an important role in the pathogenesis of peritoneal carcinosis. Patients with elevated levels of different inflammation cytokines show a worse prognosis at the time of diagnosis. In women, ovarian and colon cancer are the main causes of peritoneal carcinosis and a comparison of these two different types of peritoneal invasion have not been conducted yet. We found interesting studying the role of immune response, in particular tumour-associated antigens (TAA) that modulate the metastatic process. We will investigate also mitochondrial defects, such as mutations in mt-DNA, potentially involved in carcinogenesis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

October 9, 2019

Last Update Submit

November 21, 2019

Conditions

Peritoneal CarcinomatosisOvarian CancerColon Cancer

Keywords

peritoneal carcinomatosiscolon cancerovarian cancerP2X7R-inflammasome

Outcome Measures

Primary Outcomes (3)

  • Immune biomarkers level

    Serum level of different immune related biomarkers (such as CD4, CD8, CUZD1, LAG3, PD1, PDL1, IMP1 and p62/IMP2) will be determined using ELISA.

    Each patients will be assessed at baseline

  • Metastatic mediators level

    Peritoneal expression of cytokines related to metastatic process (such as IL6, IL2, TNFα, TGFβ1, VEGF, CD68, FGFR1, CCL2/MCP-1, CD73) will be determined using real time-PCR.

    Each patients will be assessed at baseline

  • P2X7R-inflammasome activity

    Peritoneal expression of NLRP3-ASC will be determine using RT-PCR

    Each patients will be assessed at baseline

Study Arms (2)

Ovarian cancer

Patients affected by ovarian cancer will be stratified according to BRCA1 and BRCA2 mutational status.

Procedure: Cytoreductive surgery

Colon cancer

Patients affected by colon cancer will be similarly stratified according to BRAF and KRAS mutational status and to the presence of low-grade or high-grade microsatellite instability (MSI).

Procedure: Cytoreductive surgery

Interventions

Cytoreductive surgeryPROCEDURE

Partial removal of peritoneal tissue involved by neoplastic invasion

Also known as: Debulking
Colon cancerOvarian cancer

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study consecutively enrolled 30 patients undergoing surgical treatment for peritoneal carcinosis: 15 patients affected by high grade ovarian cancer and 15 patients affected by colon cancer. Patients will be enrolled among those referring to the Gynaecologic Unit and the General Surgery Unit, University Hospital of Pisa, Italy.

You may qualify if:

  • histological diagnosis of peritoneal carcinosis secondary to colon cancer or high-grade ovarian cancer
  • patients able to consent

You may not qualify if:

  • previous malignancies, except for patients with cutaneous basal cell carcinoma, Cervical Intraepithelial Neoplasia (CIN) or melanoma in situ
  • current chemotherapy or radiotherapy
  • current steroid therapy or immunotherapy
  • patients affected by systemic inflammatory disease and/or Inflammatory bowel disease (IBD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pisa

Pisa, 56125, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

peritoneal biopsy

MeSH Terms

Conditions

Peritoneal NeoplasmsOvarian NeoplasmsColonic Neoplasms

Interventions

Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Anna Solini, MD, PhD

    University of Pisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 10, 2019

Study Start

March 1, 2017

Primary Completion

June 1, 2018

Study Completion

March 30, 2019

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations

IT(1)